Health

Social and Legal Concerns as America Expands into the Brain-Computer Interface

January 31, 2017
Criminal Law, Health, New Technology

Daniel Baum, MJLST Staffer

A great deal of science and technology has been emerging in the field of the brain-computer interface, the connection between the human brain and machines. In addition to forming effective prosthetics and helping doctors repair brain damages, technology in the brain-computer interface has recently allowed a man to operate a prosthetic hand and an electric wheelchair with his mind using only a microelectrode array surgically implanted into his arm’s nerve fibers. The professor who developed the implant also experimented on himself, and made himself able to see in the dark: with an implant into the median nerve of his wrist, he could use the electric feedback from an ultrasonic range-finding sensor mounted on his hat to guide himself around a room blindfolded. Since this technology is still in its experimental stages, American law does not have much to say about human enhancements. Already, dangerous medical devices can lead to confusing and unfair trials, and it’s easy to imagine courtrooms getting even more confusing and unfair as medical devices progress into the brain-computer interface. This technology is close enough that the implementation of legal changes now could help this emerging technology develop in ways that will balance minimizing harm with utilizing its enormous potential to make people better.

Current laws impose no affirmative duty on manufacturers to allow pacemaker users access to their own data, and the top five manufacturers do not allow patients to access the data produced by their own pacemakers at all. As we begin to view machines as extensions of ourselves, in order to maintain our personal autonomy, we will need to be able to control who accesses the data we produce. This calls for an already necessary legal change: a right to access and control access to the data generated by objects that are effectively extensions of ourselves.

As this technology moves from healing disabled humans to giving normal people supernormal powers, its use will become much more widely pursued—“the disabled may prove more abled; we may all want their prostheses.” If other job applicants are capable of so much more because of their built-in brain-computer interface technology, employers may discriminate against natural, unenhanced humans. To protect people who cannot or who choose not to install machinery in the brain-computer interface, for financial, medical, ethical, religious, or any reasons, an independent statutory scheme with the purpose of eliminating discrimination both for and against individuals with brain-computer interface devices would not disturb the currently established disability protocols in the Americans with Disabilities Act and could be amended to account for each new form of machinery.

Another frightening concern arises once these enhancements become capable of connecting to the internet: if someone hacks into somebody else’s machinery and makes that person damage something or someone, who will be criminally and civilly liable for the damage? Since American law does not have much to say about human enhancements, no defense has been defined for the person who was hacked into and forced to cause harm. The person whose body actually committed the act could try pleading the affirmative defense of duress—that is, the defendant was compelled to commit the crime against his or her will or judgment—but the U.S. Supreme Court held in 2014 in Rosemond v. United States that “circumstances that traditionally would support a necessity or duress defense” require proof that the defendant “could have walked away.” The hacker took away the defendant’s control of his or her own body, making it impossible for the defendant to have walked away. To solve this problem, states that recognize the defense of insanity could amend their statutes to allow defendants who were mentally unable to control their own bodies due to hacking to plead the affirmative defense of insanity. States that conform to the Federal Rules of Criminal Procedure would then order the defendant to be mentally examined by an expert who could determine and tell the court to what extent the defendant was in control of his or her own mind and body at the time of the crime. The defendant could them implead the hacker to shift the liability for committing the crime. However, since the insanity defense is a mental health defense and brain-computer interface devices aren’t necessarily related to mental health, states may want to define a new affirmative defense for being hacked into that follows a similar procedure but that better fits the situation and that doesn’t carry the stigma of mental disorder.

New machinery in the brain-computer interface is exciting and will allow us both to heal physical and mental damages and to develop supernormal powers. Legal changes now could help this emerging technology develop in ways that will balance minimizing harms like invasions of privacy, discrimination, and hacking with utilizing its enormous potential to make people better.

Ensuring a Fair Trial in Medical Device Cases

January 21, 2017
FDA, Health, Medical Devices

Frank Griffin, M.D., J.D., Adjunct Professor, University of Arkansas School of Law

Dangerous medical devices have been in the news, and the Institute of Medicine—upon the FDA’s request—made recommendations to make device approval pathways safer, but little has changed.  Orthopaedic device companies use the pathway that the Institute of Medicine called “flawed” to gain approval of 88% of their devices—resulting in an 11.5 times higher recall rate than if a more rigorous pathway to approval were chosen.  Predictably, patients are often harmed by recalled devices (and likely other devices that are not officially recalled), but harmed patients may have no choice but to suffer the “overwhelming misfortune” (envisioned in Escola) of shouldering the burden of the companies’ design choices in the current unnecessarily prejudicial legal environment.

In Daubert v. Merrell Dow Pharmaceuticals, the United States Supreme Court provided a framework for judges’ gatekeeper role in assessing the reliability and relevancy of scientific expert testimony to be heard by the jury.  Unfortunately, judges may be overwhelmed and unintentionally unfair in handling a task that some judges from the beginning considered “daunting” complaining they were “no match” for the experts they face.  Since Daubert, in limine challenges have increased, “primarily driven by a significant increase in the number of in limine challenges raised against plaintiff expert witnesses.”

However, there is hope for the overwhelmed judge sorting through the pretrial in limine motions regarding scientific experts in complex orthopaedic cases.  As explored in depth in my recent article to allow for a fair trial, judges should place defense experts and epidemiology studies under greater scrutiny, while being more willing to admit the few experts available to plaintiffs in these often-novel cases.  In addition, courts should require all experts to file conflict of interest disclosure forms under penalty of perjury similar to those used in the orthopaedic journals to assist with assessment of reliability—given that an overwhelming (>97%) majority of experts with stock options, consulting contracts, employment contracts or royalties report positive outcomes in their studies, and also considering that studies are generally reproducible only when <25% of the data comes from developers.  On the plaintiffs’ side, judges should be more open to allowing experience experts and experts who do their research in preparation for trial—because in these novel cases, no other non-industry experts may exist to expose problems.

My article—“Prejudicial Interpretation of Expert Reliability on the ‘Cutting Edge’ Enables the Orthopaedic Implant Industry’s Bodily Eminent Domain Claim”—highlights information of which courts, attorneys, doctors, and patients should be aware.  The article provides ways that the court may stand on equal ground with experts in these complex cases to fairly assess reliability and to do its part to create a safer and more effective medical device market that does not unnecessarily “take” Americans’ health.

A New Year! A New You!: Update Your Look on Regenerative Healing Law

January 2, 2017
Bioethics, FDA, Health, Patents

Angela Fralish, MJLST Invited Blogger

Stephen Breyer, Associate Justice for the Supreme Court remarked that in this age of science, we must build legal foundations that are sound in science as well as in law, because a judge is not a scientist and a courtroom is not a scientific laboratory. Further, our decisions should reflect a proper scientific and technical understanding so that the law can respond to the needs of the public.

Human regenerative healing from embryonic stem cell research has sparked many debates on the public’s needs. On one hand, this research has the ability to relieve great suffering and even death, but on the other hand, it is accompanied by the using and destroying of human life. Moral controversy is a dark cloud looming over any courthouse looking to rule on the science of regenerative healing.

Legislative measures have ebbed and flowed with presidencies. Presidents Clinton, Bush and Obama have used executive orders to either expand or reduce federal funding of regenerative healing. President-Elect Trump’s policy is unknown. According to an NPR article issued in November 2016, “his campaign said little about research and development in general, or health research in particular.” This will be an important point in the near future as a Swedish scientist broke taboo in September of this year by altering healthy human embryos. Further, the NIH plans to lift the ban on regeneration in chimeras in early 2017. As it stands, the federal perspective towards future regenerative healing technology remains unclear.

The most recent executive response has been the Cures Act signed on December 13th of last year by President Obama. Sections 3033-3036 support an expedited FDA review of regenerative therapies and demand an update to regulatory law. Practically speaking, this means that clinical trials will be shortened to get the product on the market faster. While some worry this change will compromise ethics, others worry about the United States ability to keep up with a global market. Dr. Brenda Canine quotes, “If concerted long-term investments in research are not made, America will lose an entire generation of young scientists.”

One established principle in regenerative healing is ownership rights under intellectual property law. Challenges have been made on the grounds that researchers are attempting to patent “life,” but courts have allowed ownership rights to certain cell lines. Dr. Nicholas Zachariades wrote in his article titled Stem Cells: Intellectual Property Issues in Regenerative Medicine that “with respect to the stem cells and their use in the field of regenerative medicine, the U.S. Patent and Trademark Office has recognized inventions involving stem cells as patent-eligible subject matter.” He cites to Consumer Watchdog v. Wisconsin Alumni Research Foundation (WARF)  where the plaintiff sued WARF for the patent being too broad, but lost because they lacked standing. WARF maintains a valid patent for “in vitro cell culture.”

Keeping up with science will continue to be a challenge. While it is against norms to destroy healthy embryos, there is a pressing need for the U.S. to compete in a global market. Hopefully, researchers, lawyers and politicians will eventually find a way to merge ethical, legal and federal funding policies related to stem cell research and regenerative healing into a solid legal foundation.

Drinking the Kool-Aid? Why We Might Want to Talk About Our Road Salt

November 1, 2016
Environment, Health, Public Health

Nick Redmond, MJLST Staffer

Winter is coming. Or—at least according to the 2017 Farmer’s Almanac—“winter is back” after an exceptionally mild 2015–2016 season, and with it comes all of the shoveling, the snow-blowing, and the white walkers de-icing of slippery roads that we missed last year. So what does the most overused Game of Thrones quote and everyone’s least favorite season have to do with Kool-Aid (actually, Flavor-Aid)? Just like the origins of the phrase “drinking the Kool-Aid,” this post has to do with cyanide. More specifically, the ferrocyanide compounds that we use to coat our road salt and that are potentially contaminating our groundwater.

De-icing chemicals are commonly regarded as the most efficient and effective means of keeping our roads safe and free from ice in the winter. De-icing compounds come in many forms, from solids to slurries to sticky beet juice- or cheese brine-based liquids. The most common de-icing chemical is salt, with cities like Minneapolis spending millions of dollars to purchase upwards of 15,000 tons of treated and untreated salt to spray on their roads. In order to keep the solid salt from clumping or “caking” and becoming unusable as it sits around it’s usually treated with chemicals to ensure that it can be spread evenly on roads. Ferrocyanide (a/k/a hexacyanoferrate(II)) and the compounds sodium ferrocyanide and potassium ferrocyanide are yellow chemicals commonly used as anti-caking additives for road salt in Minnesota and other parts of the country, and they can be found in varying concentrations depending on the product, from 0.0003 ppm to 0.33 ppm. To put those numbers in perspective, the CDC warns that cyanide starts to produce harmful effects on humans at 0.05 mg/dL, or 0.5 ppm.

But why are chemicals on our road salt troubling? Road salt keeps ice from forming a bond with the pavement by lowering the freezing point of snow as it falls on the ground. As the salt gets wet it dissolves; it and the chemicals that may be attached to it have to go somewhere, which may be our surface and ground waters or the air if the liquids evaporate. The introduction of these chemicals into groundwater is of particular concern for the 75% of Minnesotans and people like them who rely on groundwater sources for drinking water. The potential for harm arises when ferrocyanide compounds are exposed to light and rapidly decompose, yielding free cyanide (CN and HCN). Further, as waters contaminated with cyanide are chlorinated and introduced to acids they may produce the harmful compound cyanogen chloride, a highly toxic gas that was once considered for use in chemical warfare. Taking into account the enormous amount of salt used and stored each year, even small concentrations may add up over time. And although the EPA has placed cyanide on the Clean Water Act’s list of toxic substances, the fact that road salt is a non-point source means that it’s entirely up to states and municipalities to decide how they want to regulate it.

The good news is that ferrocyanides are among the least toxic cyanide salts, and tend not to release toxic free cyanide. What’s more, the concentrations of ferrocyanide on road salt are generally quite low, are spread out over large areas, and are even further diluted by precipitation, evaporation, and existing ground and surface water. In order to really affect drinking water the ferrocyanide has to (1) not evaporate into the air, (2) make its way through soil and into aquifers, and (3) in large enough concentrations to actually harm humans, something that can be difficult for a large molecule. Despite all of this, however, the fact that Minneapolis alone is dumping more than 15,000 tons of road salt each year, some of it laced with ferrocyanide, should give us pause. That’s the same weight as 15,000 polar bears being released in the city streets every year! Most importantly, these compounds seep into our garden soil, stick to our car tires and our boots, and soak the fur of our pets and wild animals. While cyanide on road salt certainly isn’t a significant public health risk right now, being a part of local conversations to explore and encourage alternatives (and there are a number of alternatives) to prevent future harm might be something to consider.

At the very least think twice about eating snow off the ground (if you weren’t already). Especially the yellow stuff.

Home | Contact Publishing Services | My Account